Using Oasis ECM to treat donor site wounds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of Oasis extracellular matrix (ECM) for treating donor site wounds in patients over 16 years old in the United Kingdom. Approximately 40 participants will be enrolled, with half receiving Oasis ECM and the other half receiving standard wound care. The study aims to assess how well Oasis ECM promotes healing in comparison to conventional methods. Participants must have a specific type of skin graft donor site wound that requires a covering material.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Has a split thickness skin graft (STSG) donor site wound no greater than 14 x 20 cm in size requiring placement of a covering material.
2. Has at least 24 hours to consent to study participation.

Exclusion Criteria:

1. Age \< 16 years
2. Patients who, in the opinion of the investigator, have co-morbidities that impair wound healing, such as:

   1. Chronic inflammatory skin condition
   2. Chronic liver failure
   3. Chronic renal failure
   4. Blood-borne viruses (Hep B, Hep C, HIV)
   5. Peripheral vascular disease
   6. Clinically significant anaemia
   7. Uncontrolled diabetes
3. Need for use of the same harvest site (re-cropping)
4. History of radiation therapy to proposed donor site
5. Chronic use of medications known to impair wound healing
6. Chronic use of opioids or neuropathic pain agents
7. Suspected cellulitis, osteomyelitis or septicaemia
8. Patients undergoing haemodialysis
9. Patients requiring spinal/regional block
10. Patients on current anti-coagulant therapy
11. Unable or unwilling to provide informed consent
12. Unable or unwilling to comply with the study follow-up schedule, and procedures
13. Simultaneously participating in another investigational drug or device study (patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrolment in this study)
14. Allergy or hypersensitivity to materials that are porcine-based
15. Cultural or religious objection to the use of pig or porcine products
16. Known intolerance/allergy to standard wound care products
17. Presence of a local infection at the donor site and/or systemic infection

Where it's running

• Manchester University NHS Foundation Trust
  Manchester, England, United Kingdom Recruiting

Study contacts

• Study coordinator: Carina Gregory, MS
• Email: cgregory@rtix.com
• Phone: 765-497-3355

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.